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临床试验/NCT04787458
NCT04787458已完成不适用

Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery(ABC) : a Randomized Controlled Trial

Kangbuk Samsung Hospital1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2020年8月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
degree of comfort

研究概览

简要总结

There have been reports that abdominal binder use after laparoscopic or open surgery affects postoperative respiratory function, walking performance, and pain but no study has evaluated binder use solely for laparoscopic cholecystectomy surgery. Therefore, the investigators performed a randomized controlled trial to evaluate the effect of abdominal binders after laparoscopic cholecystectomy by comparing postoperative outcomes in two patient groups.

详细描述

Abdominal binders help to prevent postoperative complications, however, their use is controversial because of a lack of evidence for their effectiveness and because they also confer disadvantages. The purpose of this randomized controlled trial was to compare the effects of abdominal binder after laparoscopic cholecystectomy on pain, degree of comfort, time until ambulation, walking ability, return of bowel function, and diet resumption.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 years old
  • American Society of Anesthesiologists Physical Status classification I and II

排除标准

  • history of ventral hernia
  • walking disability
  • chronic obstructive respiratory disease
  • malignancy
  • chronic pain syndrome
  • open conversion
  • inability to complete the questionnaire

结局指标

主要结局

degree of comfort

时间窗: Until dischage, an average of 2.5 days

Questionnaire response options ranged from very comfortable (5) to very Questionnaire response options ranged from very comfortable (5) to very uncomfortable (0).

postoperative pain

时间窗: 48 hours after surgery

Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 48 hours after surgery

次要结局

  • Postoperative hospital stay(Until dischage, an average of 2.3 days)

研究者

发起方
Kangbuk Samsung Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sung Ryol Lee

Hepato-biliary and pancreatic department of General Surgery, Assistant Professor

Kangbuk Samsung Hospital

研究点 (1)

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